Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002)

NCT ID: NCT03983980

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 515 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2020-05-29

Brief Summary

This is a randomized double-blind vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.

Detailed Description

This study is a 12-week double-blind, vehicle-controlled treatment study in which subjects will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 12 weeks. At the end of the 12-week study treatment, qualified subjects completing the study will have the option to enter a separate open-label, long-term safety and efficacy study for an additional 40 weeks of treatment with tapinarof cream, 1%. Subjects who do not enroll in the open-label long-term study will complete a follow-up visit approximately 4 weeks after end of treatment in this study (at Week 16).

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tapinarof (DMVT-505) Cream Group

Tapinarof cream, 1%, applied once daily

Group Type: EXPERIMENTAL

Tapinarof

Intervention Type: DRUG

Tapinarof cream, 1%, applied once daily

Vehicle Cream Group

Vehicle cream applied once daily

Group Type: PLACEBO_COMPARATOR

Vehicle Cream

Intervention Type: DRUG

Vehicle cream applied once daily

Interventions

Tapinarof

Tapinarof cream, 1%, applied once daily

Intervention Type: DRUG

Vehicle Cream

Vehicle cream applied once daily

Intervention Type: DRUG

Other Intervention Names

DMVT-505

Eligibility Criteria

Inclusion Criteria

• Male and female subjects ages 18 to 75 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 6 months prior to the study.
• BSA involvement ≥ 3% and ≤ 20%
• A PGA score of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline
• Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study, including screening, during the treatment period, and for at least 4 weeks after the last exposure to study treatment
• Capable of giving written informed consent

Exclusion Criteria

• Psoriasis other than plaque variant
• Any sign of infection of any of the psoriatic lesions
• Concurrent conditions or history of other diseases:
• Immunocompromised at Screening
• Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the Baseline visit
• Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week prior to the Baseline visit
• Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5x the upper limit of normal (ULN)
• Total bilirubin > 1.5 x ULN; total bilirubin > ULN and ≤ 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%
• Corrected QT interval > 475
• Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result, or a positive anti-hepatitis B core antigen (anti-HBc) result
• Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis
• Use of any prohibited medication within the indicated period before the first dose of study drug
• Within a minimum of 5 half-lives for biologic agents:

• Within 4 weeks for systemic immunosuppressive or immunomodulating agents, fumaric acid derivatives, vitamin D3 and analogs, retinoids, psolarens, corticosteroids, adrenocorticotropic hormone analogs, and tazarotene
• 2 weeks for immunizations with a live viral component; drugs known to possibly worsen psoriasis, unless on a stable dose for > 12 weeks
• With the exception of non-medicated emollients, 2 weeks for topical treatments including corticosteroids, immunomodulators, anthralin (dithranol), vitamin D derivatives or coal tar.
• Pregnant females or lactating females
• History of sensitivity to the study drugs, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates the subject's participation in the study
• The subject has received an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug
• Current or a history of cancer within 5 years except for fully excised skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
• Subjects with active infection that required oral, intramuscular, or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days of Baseline/Day 1
• Previous known participation in a clinical study with tapinarof
• Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or CV system abnormalities or laboratory abnormality that will affect the health of the subject or interfere with interpretation of the results

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

IQVIA Biotech

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria Butners

Role: STUDY_DIRECTOR

Dermavant Sciences GmbH

Locations

Dermavant Investigative Site

Fort Smith, Arkansas, United States

Dermavant Investigative Site

Fountain Valley, California, United States

Dermavant Investigative Site

Fremont, California, United States

Dermavant Investigative Site

Los Angeles, California, United States

Dermavant Investigative Site

Oceanside, California, United States

Dermavant Investigative Site

San Diego, California, United States

Dermavant Investigative Site

Santa Monica, California, United States

Dermavant Investigative Site

Denver, Colorado, United States

Dermavant Investigative Site

Boynton Beach, Florida, United States

Dermavant Investigative Site

Margate, Florida, United States

Dermavant Investigative Site

Miami, Florida, United States

Dermavant Investigative Site

Boise, Idaho, United States

Dermavant Investigative Site

Rolling Meadows, Illinois, United States

Dermavant Investigative Site

Plainfield, Indiana, United States

Dermavant Investigative Site

Overland Park, Kansas, United States

Dermavant Investigative Site

Louisville, Kentucky, United States

Dermavant Investigative Site

Owensboro, Kentucky, United States

Dermavant Investigative Site

Metairie, Louisiana, United States

Dermavant Investigative Site

Boston, Massachusetts, United States

Dermavant Investigative Site

Bay City, Michigan, United States

Dermavant Investigative Site

Detroit, Michigan, United States

Dermavant Investigative Site

Fort Gratiot, Michigan, United States

Dermavant Investigative Site

Fridley, Minnesota, United States

Dermavant Investigative Site

Omaha, Nebraska, United States

Dermavant Investigative Site

Las Vegas, Nevada, United States

Dermavant Investigative Site

East Windsor, New Jersey, United States

Dermavant Investigative Site

Hackensack, New Jersey, United States

Dermavant Investigative Site

Stony Brook, New York, United States

Dermavant Investigative Site

Wilmington, North Carolina, United States

Dermavant Investigative Site

Winston-Salem, North Carolina, United States

Dermavant Investigative Site

Beachwood, Ohio, United States

Dermavant Investigative Site

Bexley, Ohio, United States

Dermavant Investigative Site

Portland, Oregon, United States

Dermavant Investigative Site

Charleston, South Carolina, United States

Dermavant Investigative Site

Nashville, Tennessee, United States

Dermavant Investigative Site

Houston, Texas, United States

Dermavant Investigative Site

Pflugerville, Texas, United States

Dermavant Investigative Site

Plano, Texas, United States

Dermavant Investigative Site

San Antonio, Texas, United States

Dermavant Investigative Site

Webster, Texas, United States

Dermavant Investigative Site

Norfolk, Virginia, United States

Dermavant Investigative Site

Spokane, Washington, United States

Dermavant Investigative Site

Edmonton, Alberta, Canada

Dermavant Investigative Site

Surrey, Bristish Columbia, Canada

Dermavant Investigative Site

Surrey, Bristish Columbia, Canada

Dermavant Investigative Site

Etobicoke, Ontario, Canada

Dermavant Investigative Site

Hamilton, Ontario, Canada

Dermavant Investigative Site

Markham, Ontario, Canada

Dermavant Investigative Site

Oakville, Ontario, Canada

Dermavant Investigative Site

Ottawa, Ontario, Canada

Countries

United States; Canada

References

Lebwohl MG, Stein Gold L, Strober B, Papp KA, Armstrong AW, Bagel J, Kircik L, Ehst B, Hong HC, Soung J, Fromowitz J, Guenthner S, Piscitelli SC, Rubenstein DS, Brown PM, Tallman AM, Bissonnette R. Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis. N Engl J Med. 2021 Dec 9;385(24):2219-2229. doi: 10.1056/NEJMoa2103629.

Reference Type: BACKGROUND

PMID: 34879448 (View on PubMed)

Gold LS, Bruno MJ, Lewitt GM, Hebert AA. Characteristics and management of follicular events and contact dermatitis in patients using tapinarof cream for the treatment of atopic dermatitis or plaque psoriasis. J Dermatolog Treat. 2025 Dec;36(1):2517388. doi: 10.1080/09546634.2025.2517388. Epub 2025 Jul 2.

Reference Type: DERIVED

PMID: 40600584 (View on PubMed)

Kircik L, Zirwas M, Kwatra SG, Lewitt GM, Glover H, Chao T, Brown PM, Rubenstein DS, Tallman AM. Rapid Improvements in Itch with Tapinarof Cream 1% Once Daily in Two Phase 3 Trials in Adults with Mild to Severe Plaque Psoriasis. Dermatol Ther (Heidelb). 2024 Jan;14(1):201-211. doi: 10.1007/s13555-023-01068-x. Epub 2023 Dec 21.

Reference Type: DERIVED

PMID: 38123875 (View on PubMed)

Desai SR, Stein Gold L, Cameron MC, Golant A, Lewitt GM, Bruno MJ, Martin G, Brown PM, Rubenstein DS, Butners V, Tallman AM. Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials. Dermatol Ther (Heidelb). 2023 Oct;13(10):2443-2460. doi: 10.1007/s13555-023-01008-9. Epub 2023 Sep 11.

Reference Type: DERIVED

PMID: 37697121 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DMVT-505-3002

Identifier Type: -

Identifier Source: org_study_id